The clinical-stage company Auris Medical (NASDAQ:EARS) has emerged as an early winner this morning after its stock soared by 23%. This morning the company announced additional information with regards to the results from the clinical trial into its product Bentrio.
The product is a nasal spray and is meant for treating people suffering from allergic rhinitis. In addition to that, the company also provided an important update in relation to the regulatory path for the product in the United States.
Auris announced that in the clinical study into the Bentrio managed to hit the primary endpoint in relation to the clinical evaluation into allergic rhinitis. More importantly, the reduction in nasal symptoms was not only significant but also clinically relevant. On the other hand, the product was also given high efficacy rating by clinicians as well as patients. In the pre-submission meeting with the FDA, it emerged that the agency supports a 510(k) regulatory path.
EARS stock is now up by 23.34% at $3.54, well off the session high of $4.34